The Efficacy of Self-Manufactured 40% Dextrose Gel as Supplementary to Asymptomatic Transient Neonatal Hypoglycemia Treatment : A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 3
- 主要终点
- Blood Glucose Serum Levels
研究概览
简要总结
The goal of this clinical trial is to determine the efficacy of 40% dextrose gel therapy as an additional therapy for the management of asymptomatic transient neonatal hypoglycemia in high risk infants
The main question it aims to answer is:
Is 40% dextrose gel effective for the management of asymptomatic transient NH in high risk infants?
Researchers will compare the use of 40% dextrose gel as an additional therapy to the standard treatment and the use of breastmilk or formula milk according standard hypoglycemia treatment only to see if 40% dextrose gel is superior than standard therapy for management as asymptomatic transient NH in high risk infants.
Participants will :
- Receive 40% dextrose gel plus standard therapy or standard therapy only
- Blood glucose level measurement (30 minutes after intervention)
详细描述
Background: Neonatal hypoglycemia (NH) is a metabolic disorder that often occurs in the first few days of life. It is a potential cause of preventable brain injury and neonatal death. Most of hypoglycemia in high risk infants are transient and asymptomatic. One of the additional therapy for asymptomatic transient neonatal hypoglycemia is 40% dextrose gel. The 40% dextrose gel is a promising therapy because it is inexpensive, easy to administer and non-invasive.
Objective
To determine the efficacy of 40% dextrose gel therapy as an additional therapy for the management of asymptomatic transient NH in high risk infants.
Methods: A single-blind, randomized controlled trial was carried out in April-August 2023. The inclusion criteria were infants >34 weeks of gestational age and birth weight >1500 grams with blood sugar levels of 27-<47 mg/dL and without hypoglycemic symptoms. Block randomization was carried out in 60 eligible subjects. Subjects were allocated to 2 groups, the treatment group (40% dextrose gel plus standard therapy) and control group (standard therapy). The self-manufactured 40% dextrose gel was applied in buccal mucosa region. Blood glucose level was measured with glucometer 30 minutes after intervention. Data presented in descriptive and analyzed using chi-square and independent t-test with p<0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 34 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with gestational age >34 weeks and birth weight >1500 grams with one of risk factors for hypoglycemia, such as baby with large for gestational age (LGA), small for gestational age (SGA), intrauterine growth restriction (IUGR), late preterm infants (LPIs), history of antenatal corticosteroid administration for 24 hours to 7 days before delivery; Maternal risk factors: hypertensive mothers, preeclampsia, diabetes type 1 or 2 mothers during or before pregnancy, consumed medication that caused hypoglycemia (terbutaline, b-blockers)
- •Blood sugar levels at 0-4 hours after delivery are 27-<47 mg/dL,
- •The parents agreed to participate in the research
排除标准
- •birth asphyxia that require active resuscitation and neonatal intensive care unit (NICU) care
- •infants with symptoms of hypoglycemia
- •Infants who have absolute and relative contraindications for enteral and oral feeding.
研究组 & 干预措施
Intervention Group
Intervention group : given self manufactured 40% dextrose gel applied in buccal mucosa region plus standard therapy
干预措施: self-manufactured 40% dextrose gel (Drug)
Intervention Group
Intervention group : given self manufactured 40% dextrose gel applied in buccal mucosa region plus standard therapy
干预措施: Standard therapy (Drug)
Control Group
Control group : given a standard therapy only
干预措施: Standard therapy (Drug)
结局指标
主要结局
Blood Glucose Serum Levels
时间窗: From enrollment to 30 minutes after intervention
Blood glucose level was measured from capillary blood with glucometer which validated every two weeks by supervised technician. Blood serum obtained by skilled health workers at 30 minutes after intervention.
次要结局
未报告次要终点
研究者
Rosalina Dewi Roeslani
Principal Investigator
Indonesia University